Male InfertilityPhase 1NCT01595308
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
A Phase 1 study testing Pomegranate juice in people with Male Infertility, run by POM Wonderful LLC at 1 site in United States.
Trial summary
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Pomegranate juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 12 healthy men aged 18-40
- normal sperm counts
Who cannot join
- History of undescended testes or surgery to the scrotal contents,
- History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study
- No alpha adrenergic medications within two weeks of entry into the study,
- No anabolic steroid use,
- No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Program at University of California
Los Angeles, California, 90024
About this study
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.
Read the detailed description
To determine, in this pilot study, whether daily consumption of pomegranate juice (POM) affects the concentration, morphology or motility of sperm in healthy men. The purpose of the present pilot study is to examine the hypothesis that POM may improve semen parameters in men.
- Conditions
- Male Infertility
- Being tested
- Pomegranate juice
- Keywords
- Male infertility
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate juiceDietary supplement
Pomegranate juice
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate juice | Experimental | Pomegranate juice Receives: Dietary Supplement: Pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sperm counts
The primary outcome will be change in sperm counts relative to baseline with and without POM.
Measured: Baseline and 6 months
Secondary outcomes (1)
Change in Sperm count
The secondary outcome will be change in sperm counts relative to baseline with and without POM.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- POM Wonderful LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Rajfer, MD, Principal investigator, Institute of Urologic Oncology at UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595308
- Sponsor's protocol ID
- 2010-002
- Status last verified
- May 2012
- First submitted
- 4 Apr 2012
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01595308
- Acronym / sponsor ID
- 2010-002
- Conditions
- Male Infertility
- Keywords
- Male infertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- POM Wonderful LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.
Detailed description
To determine, in this pilot study, whether daily consumption of pomegranate juice (POM) affects the concentration, morphology or motility of sperm in healthy men. The purpose of the present pilot study is to examine the hypothesis that POM may improve semen parameters in men.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomegranate juice | Experimental | Dietary Supplement: Pomegranate juicePomegranate juice |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 12 healthy men aged 18-40
- normal sperm counts
Key exclusion criteria (5 listed)
- History of undescended testes or surgery to the scrotal contents,
- History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study
- No alpha adrenergic medications within two weeks of entry into the study,
- No anabolic steroid use,
- No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomegranate juicePomegranate juice | Dietary supplement | Pomegranate juice |
Primary outcome
change in sperm counts
Time frame: Baseline and 6 months
The primary outcome will be change in sperm counts relative to baseline with and without POM.
1 secondary outcome
Change in Sperm count
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Rajfer, MD principal investigator
Institute of Urologic Oncology at UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pomegranate juice in people with Male Infertility, run by POM Wonderful LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in sperm counts (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.